Prothrombin Complex Concentrate for Cardiopulmonary Bypass
What You Need to Know Before You Apply
What is the purpose of this trial?
The overall objective of this study is to determine whether ROTEM (rotational thromboelastometry) guided dosing of four-factor prothrombin complex concentrate (4F-PCC) results in superior perioperative bleeding control compared to clinician-directed. PCC administration in adult patients undergoing high-risk cardiac surgery with cardiopulmonary bypass (CPB) who develop post-CPB coagulopathic bleeding.
Who Is on the Research Team?
Jake Rachiele, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for adults having high-risk heart surgery with a heart-lung machine who start bleeding due to blood clotting problems after the procedure. People with certain conditions or risks may not be able to join, but specific exclusions are not listed here.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Four Factor Prothrombin Complex Concentrate
Trial Overview
The study compares two ways of giving a blood-clotting medicine called four-factor prothrombin complex concentrate (4F-PCC): one group gets doses based on ROTEM test results, while the other follows standard doctor judgment. The goal is to see which method better controls surgical bleeding.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive 4-factor prothrombin complex concentrate (PCC; Kcentra) by intravenous infusion. Baseline and post-cardiopulmonary bypass ROTEM assessments are performed. Initial PCC dosing is determined using a prespecified ROTEM-guided algorithm based on clotting time (CT) prolongation relative to baseline, with dose categories ranging from 10 to 50 IU/kg. Subsequent dosing adjustments are guided by post-treatment ROTEM results using a sequential response-guided dosing strategy. Additional PCC may be administered at clinician discretion as clinically indicated.
Participants receive 4-factor prothrombin complex concentrate (PCC; Kcentra) by intravenous infusion. PCC dosing is determined by the attending cardiac anesthesiologist or cardiac surgeon based on clinical assessment and available laboratory results. No protocol-mandated ROTEM trigger or dosing algorithm is used. Additional PCC may be administered as clinically indicated according to standard practice
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
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